FDA.reportPublic FDA data

Ondansetron

Product NDC
0641-6286
11-digit product format
006416286
Labeler code
0641
Product ID
0641-6286_4936a082-34d2-4cd3-9740-3a55ac939b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA077365
Marketing category
ANDA
Marketing start
2006-12-26
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui283504, 1740467

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6286-01Ondansetron20 mL in 1 VIAL, MULTI-DOSEINJECTION2020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6286-01ML - Milliliter0641-628697e6d5e0-4294-4d5a-9094-f09176c13a7d12025-05-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
TRISODIUM CITRATE DIHYDRATEINACTIVE INGREDIENTB22547B95KONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11
WATERINACTIVE INGREDIENT059QF0KO0RONDANSETRON INJECTION [WEST-WARD PHARMACEUTICAL CORP.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6286ONDANSETRON INJECTION [HIKMA PHARMACEUTICALS USA INC.]19Current NDC, 1 package rows20250327_97713356-f42b-4a67-95f6-561afa68c0c2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283504ondansetron 2 MG/ML Injectable SolutionPSN97713356-f42b-4a67-95f6-561afa68c0c220
1740467ondansetron 4 MG in 2 ML InjectionPSN97713356-f42b-4a67-95f6-561afa68c0c220
17404672 ML ondansetron 2 MG/ML InjectionSCD97713356-f42b-4a67-95f6-561afa68c0c220
283504ondansetron 2 MG/ML Injectable SolutionSCD97713356-f42b-4a67-95f6-561afa68c0c220
283504ondansetron (as ondansetron HCl ) 2 MG/ML Injectable SolutionSY97713356-f42b-4a67-95f6-561afa68c0c220
1740467ondansetron 4 MG per 2 ML InjectionSY97713356-f42b-4a67-95f6-561afa68c0c220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0641-6286-010064162860120 mL in 1 VIAL, MULTI-DOSE (0641-6286-01) 20 ml2006-12-26NoNoCurrent